Top 27 Activity specialist Jobs in San Jose, Ca

Principal Regulatory Affairs Specialist
PROCEPT BioRobotics Corporation —San Jose, CA
- Full-time
- Microsoft Excel
- 11+ years
- Research
- Opportunities for advancement
Quick Apply
Special Education Teacher in Sunnyvale, CA
Soliant —Sunnyvale, CA
- $33.34 - $53.34 an hour
- Full-time
- Classroom
- Mid-level
- Communication skills
- Health insurance
Quick Apply
Facilities Project Specialist
MSR-FSR —Santa Clara, CA
- $62,000 - $90,000 a year
- Full-time
- 6 years
- Ability to walk for extended periods
- Presentation skills
- Disability insurance
- Health insurance
Quick Apply
Activity Leader
On Lok —San Jose, CA
- $26.45 - $35.26 an hour
- Full-time
- Spanish
- Experience working with individuals with disabilities
- English
- Commuter assistance
- AD&D insurance
Quick Apply
Billing Specialist
SILICON VALLEY MECHANICAL —San Jose, CA
- $75,000 - $110,000 a year
- Full-time
- Background check
- Microsoft Excel
- Heavy lifting
- Paid holidays
- Disability insurance
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4d
Housing Specialist-Individuals RRH
HomeFirst —San Jose, CA
- $32.20 an hour
- 8 hour shift
- Mid-level
- Driver's License
- Bachelor's degree
- Commuter assistance
- Disability insurance
5h
Executive Business Partner
Waymo —Mountain View, CA
- $158,000 - $194,000 a year
- Full-time
- Office
- Analysis skills
- Bachelor's degree
Martial Arts Instructor
Impact Kids —Berryessa, CA
- $40 - $75 an hour
- Teaching Certification
- Mid-level
- Bachelor's degree
Quick Apply
Business Development Specialist - IP/IP Litigation
WilmerHale —Palo Alto, CA
- $100,000 - $125,000 a year
- Full-time
- Business development
- Senior level
- Profit sharing
- Paid holidays
Membership Specialist
UFC Gym —Sunnyvale, CA
- $19 - $65 an hour
- Weekends as needed
- Computer literacy
- High school diploma or GED
- Organizational skills
Quick Apply
ASIC Design Engineer
Apple —Cupertino, CA
- Bachelor of Science
- Mid-level
- 3 years
4d
Installer Service Specialist
O'Reilly Automotive Stores —San Jose, CA
- $18.45 - $25.00 an hour
- ASE Certification
- Mid-level
- Team management
- Employee stock purchase plan
- Health insurance
Quick Apply
4d
BIM Manager
AlfaTech —San Jose, CA
- $95,000 - $120,000 a year
- Full-time
- Hybrid work
- 7 years
- Computer Science
- Computer literacy
Quick Apply
Enlisted Operations Careers - Military Service
U.S. Coast Guard —United States
- $32,650 - $72,540 a year
- Full-time
- No experience needed
- English
- High school diploma or GED
- Relocation assistance
- Health insurance
Quick Apply

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Principal Regulatory Affairs Specialist

PROCEPT BioRobotics Corporation -
San Jose, CA

Quick Apply

Job Details

Full-time

Benefits

Opportunities for advancement

Qualifications

FDA submissions
Computer operation
Microsoft Excel
ISO standards
Project timeline management
Bachelor's degree
Quality risk management
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Managing projects
Document viewing software
Adobe Acrobat

Full Job Description

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

Understanding PROCEPT's Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

The Opportunity That Awaits You:

The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by PROCEPT BioRobotics (“company”) from development through marketing approval and commercialization. Responsibilities include coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards, and providing regulatory guidance to project teams.

The initial role of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs.

The ideal candidate would have had previous medical device experience and looking for potential for growth.

What Your Day-To-Day Will Involve:

Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activities
Providing training, coaching and mentoring to other regulatory affairs specialists
Assisting in strategic decision making, and representing regulatory at all levels of the business
Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines
Prepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
Prepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changes
Support product development teams on regulatory issues, including review of documentation
Provide regulatory assessments for anticipated design, manufacturing, and labeling changes
Represent RA functional area in the review and approval of Engineering Change Orders (ECO)
Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials
Perform regulatory research and stay abreast of changes for US and international regulations and requirements
Provide regulatory support for quality assurance and regulatory compliance activities as required
Maintain well-organized, auditable regulatory files
Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
Understand and adhere to the PROCEPT BioRobotics EHS Policy

The Qualifications We Need You to Possess

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualifications / Skills Required

Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred
Minimum of 12 years’ experience in medical device industry with experience in regulatory affairs with direct submissions responsibilities
Knowledge of relevant Title 21 of the US code of Federal Regulations is required
Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required
Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required
Experience with Quality Management System Standard ISO 13485 is required
Experience with Risk Management Standard ISO 14971 is required
Knowledge of EU MDR regulations is required
Knowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferred
Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
Strong organization skills, able to manage multiple projects and timelines
Competence in applying scientific principles and logical thought processes in preparing regulatory documentation
Excellent oral and written communication skills
Strong attention to detail
Ability to work independently as an individual contributor and in a team environment
Knowledge of software development and software quality as it relates to regulatory submissions a plus

Quick Apply

Refine Your Search

activity specialist jobs in san jose, ca

Principal Regulatory Affairs Specialist

Special Education Teacher in Sunnyvale, CA

Facilities Project Specialist

Activity Leader

Billing Specialist

Housing Specialist-Individuals RRH

Executive Business Partner

Martial Arts Instructor

Business Development Specialist - IP/IP Litigation

Membership Specialist

ASIC Design Engineer

Installer Service Specialist

BIM Manager

Enlisted Operations Careers - Military Service

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